Drugs / Foralumab
Foralumab
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05028946 | May 2022 → Jul 2023 | Crohn disease | Tiziana Life Sciences LTD | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT05029609 | Oct 2021 → Nov 2022 | primary progressive multiple sclerosis, secondary progressive multiple sclerosis | Tiziana Life Sciences LTD | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT06879067 | Nov 2018 → Jul 2019 | — | Tiziana Life Sciences LTD | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT00805909 | Aug 2007 → Jan 2009 | acute transplant rejection | Light Chain Bioscience - Novimmune SA | Completed | No outcome recorded |
| Phase 1/2 | NCT00630643 | Jan 2006 → Dec 2007 | Crohn disease | Light Chain Bioscience - Novimmune SA | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07688239 | Jul 2026 → Jul 2027 expected | amyotrophic lateral sclerosis | Tiziana Life Sciences LTD | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06868628 | May 2025 → Apr 2027 expected | multiple system atrophy | Tiziana Life Sciences LTD | Recruiting | No outcome recorded |
| Phase 2 | NCT06890923 | Mar 2025 → Apr 2026 overdue | secondary progressive multiple sclerosis | Tiziana Life Sciences LTD | Recruiting | No outcome recorded |
| Phase 2 | NCT06292923 | Nov 2023 → Sep 2026 overdue | secondary progressive multiple sclerosis | Tiziana Life Sciences LTD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04983446 | Apr → Oct 2022 | COVID-19 | Tiziana Life Sciences LTD | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT03291249 | Dec 2017 → Dec 2018 | metabolic dysfunction-associated steatohepatitis, type 2 diabetes mellitus | Tiziana Life Sciences LTD | Withdrawn | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06802328 | — | secondary progressive multiple sclerosis | Tiziana Life Sciences LTD | Available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT06489548 Comparator | Sep 2025 → Jun 2026 overdue | Alzheimer disease | Brigham and Women's Hospital | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 67
| Date | Issuer | Release |
|---|---|---|
| 2026-09-30 | Tiziana Life Sciences LTD | Regulatory Tiziana Life Sciences Files for Orphan Drug Designation with the FDA for Intranasal Foralumab for the Treatment of Multiple System Atrophy (MSA) tizianalifesciences.com ↗
Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that it has submitted a request to the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for intranasal foralumab for the treatment of Multiple System Atrophy (MSA). |
| 2026-07-31 | Tiziana Life Sciences LTD | Results Tiziana Reports Reduction in Brain Inflammation in Third Multiple System Atrophy Patient Treated with Intranasal Foralumab tizianalifesciences.com ↗
Quantitative analysis of PET scans demonstrated reductions in inflammatory activity in clinically relevant brain regions known to be affected in MSA following treatment with intranasal foralumab. |
| 2026-05-19 | Tiziana Life Sciences LTD | Results Tiziana Announces New Positive Clinical Data for Intranasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis tizianalifesciences.com ↗
Patients showed encouraging trends in stabilization of disability as measured by the Expanded Disability Status Scale (EDSS) and meaningful improvements in fatigue as measured by the Modified Fatigue Impact Scale (MFIS). |
| 2026-05-14 | Tiziana Life Sciences LTD | Results Tiziana Reports Reduced Brain Inflammation in Multiple System Atrophy Patients Treated with Intranasal Foralumab tizianalifesciences.com ↗
Quantitative analysis of PET scans demonstrated reductions in inflammatory activity in clinically relevant brain regions known to be affected in MSA following treatment with intranasal foralumab. |
| 2026-04-16 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Publication of Positive Data Demonstrating Intranasal Anti-CD3 Antibody Attenuates Long COVID Neuroinflammation and Improves Cognitive Function tizianalifesciences.com ↗
Data from independent academic collaborators published on bioRxiv support the therapeutic potential of the Company’s lead candidate, intranasal foralumab, for Long COVID associated “brain fog”. |
| 2026-04-01 | Tiziana Life Sciences LTD | Results Tiziana Announces Data Showing Nasal Anti-CD3 Improves Cognition Associated with Aging tizianalifesciences.com ↗
In the study, nasal anti-CD3 reversed key aspects of brain aging, and improved cognition. |
| 2026-02-25 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces New Biomarker Data Showing Nasal Foralumab Downregulates CSF Inflammation, Upregulates Neuroprotective Pathways, and Correlates with Reduced Microglial Activation on PET Scans in na-SPMS Patients with PIRA tizianalifesciences.com ↗
The late-breaking poster reports results from 10 patients with non-active secondary progressive multiple sclerosis (na-SPMS) and progression independent of relapse activity (PIRA) treated with nasal foralumab in an open-label expanded-access program. |
| 2026-01-20 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces the Peer-Reviewed Publication of Clinical Study Results for Intranasal Foralumab tizianalifesciences.com ↗
The publication, titled “Nasal Foralumab for the Treatment of Progression Independent of Relapses in Patients with Non-active Secondary Progressive Multiple Sclerosis,” details the comprehensive positive results previously announced by the Company on May 6, 2025. |
| 2025-12-29 | Tiziana Life Sciences LTD | Regulatory Tiziana Files Annual Safety Report for Intranasal Foralumab with FDA tizianalifesciences.com ↗
announces the submission of its seventh annual Development Safety Update Report (DSUR) to the U.S. Food and Drug Administration (FDA). |
| 2025-08-11 | Tiziana Life Sciences LTD | Regulatory FDA Approves Tiziana Life Sciences Phase 2 IND for Multiple System Atrophy tizianalifesciences.com ↗ |
| 2025-07-21 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Immunologic Analysis of Nasal Foralumab in Moderate Alzheimer’s Patient tizianalifesciences.com ↗
Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced compelling immunologic findings from the treatment of a moderate Alzheimer’s Disease (AD) patient with intranasal foralumab. |
| 2025-05-23 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Interview Highlighting Intranasal Foralumab for the Treatment of Moderate Alzheimer’s Disease tizianalifesciences.com ↗
The reduction in brain inflammation observed in Joe Walsh represents a significant step forward in our understanding and treatment of Alzheimer’s disease. |
| 2025-05-15 | Tiziana Life Sciences LTD | Results Journal of Clinical Nuclear Medicine Publishes Results of Tiziana’s Nasal Foralumab in Study Treating Moderate Alzheimer’s Disease tizianalifesciences.com ↗
The findings revealed a notable reduction in neuroinflammation following intranasal foralumab administration. |
| 2025-05-09 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Significant Reduction in Microglia Activation in PET Scan of Moderate Alzheimer’s Patient Treated with Intranasal Foralumab tizianalifesciences.com ↗
The microglial TSPO PET scan revealed a significant decrease in microglia activation, a key indicator of neuroinflammation associated with Alzheimer’s disease progression. |
| 2025-05-06 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Comprehensive Positive Results from Study of Nasal Foralumab in Patients with Multiple Sclerosis tizianalifesciences.com ↗
TSPO-PET imaging showed significant reductions in microglial activation at six months (p<0.05). |
| 2025-03-04 | Tiziana Life Sciences LTD | Regulatory Tiziana Life Sciences Files Investigational New Drug Application with FDA for ALS Phase 2 Clinical Trial tizianalifesciences.com ↗
Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced the submission of its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a phase 2 clinical trial in ALS. |
| 2025-02-27 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Groundbreaking Study Published in Nature Neuroscience Demonstrating Positive Results for Nasal Anti-CD3 Therapy in Traumatic Brain Injury tizianalifesciences.com ↗
These included, less anxiety, less cognitive decline, and improved motor skills, in a preclinical model of traumatic brain injury (TBI). |
| 2025-01-23 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Positive Results in Treating Spinal Cord Injury With Nasal Anti-CD3 tizianalifesciences.com ↗
In these studies, the preclinical model was subjected to a spinal cord injury and then was treated with nasal anti-CD3, resulting in notable advancements in motor functions. |
| 2025-01-22 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Discovery of New Immune Biomarkers in Multiple Sclerosis Patients Treated with Nasal Foralumab tizianalifesciences.com ↗
The study identified gene expression changes which were detected beginning three months after intranasal dosing of foralumab in our ongoing ISPPEA (or expanded access program). |
| 2025-01-10 | Tiziana Life Sciences LTD | Results Tiziana Announces Reduction of Side Effects Commonly Seen with Discontinuation of GLP-1 Agonists with Nasal Anti-CD3 tizianalifesciences.com ↗
This advancement offers a promising approach to overcoming the tolerability challenges and adverse effects commonly linked to prolonged GLP-1 drug use. |
| 2024-10-30 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Positive Results from Ozempic and Nasal Anti-CD3 Combination Study tizianalifesciences.com ↗
The data show that the combination of nasal anti-CD3 plus semaglutide improves liver homeostasis and reduces inflammation in models of diet-induced obesity (DIO), providing a potential novel approach to combat obesity-related inflammation, and liver inflammation and dysfunction. |
| 2024-07-24 | Tiziana Life Sciences LTD | Regulatory Tiziana Life Sciences Granted FDA Fast Track Designation tizianalifesciences.com ↗ |
| 2024-06-26 | Tiziana Life Sciences LTD | Regulatory Tiziana Life Sciences to Dose First Patient with Moderate Alzheimer’s Disease with Foralumab tizianalifesciences.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has allowed intranasal foralumab to be used under an Expanded Access (EA) IND in its first patient with moderate Alzheimer’s disease. |
| 2024-06-11 | Tiziana Life Sciences LTD | Regulatory FDA Accepts Tiziana Life Sciences Fast Track Designation Submission for Treatment of Multiple Sclerosis tizianalifesciences.com ↗
today announced it has received acceptance of its submission for intranasal foralumab to receive Fast Track Designation approval for the treatment of non-active, secondary-progressive multiple sclerosis (na-SPMS) to the U.S. Food and Drug Administration (FDA). |
| 2024-06-06 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Six-Month Qualitative Improvement in Neuroimaging in 80% of Multiple Sclerosis Patients Receiving Intranasal Foralumab tizianalifesciences.com ↗
Qualitative improvements in PET imaging seen in 80% of non-active Secondary Progressive Multiple Sclerosis (na-SPMS) Expanded Access patients receiving intranasal foralumab for at least 6-months. |
| 2024-05-13 | Tiziana Life Sciences LTD | Regulatory Tiziana Life Sciences Files for Orphan Drug Designation for Intranasal Foralumab tizianalifesciences.com ↗
today announced it has submitted an FDA request to obtain Orphan Drug Designation for intranasal foralumab for the treatment of non-active secondary progressive Multiple Sclerosis (na-SPMS). |
| 2024-04-25 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Reports Positive 3-Month Neuroimaging Scores in Multiple Sclerosis Patients Receiving Intranasal Foralumab tizianalifesciences.com ↗
We saw reductions of 28% to 48%, indicating improvement in 5 out of 6 patients, and a 36% median reduction in White Matter Z-scores compared to baseline (see Figure 1). |
| 2024-04-23 | Tiziana Life Sciences LTD | Regulatory Tiziana Life Sciences Announces FDA Allowance for Additional Twenty Patients to be Enrolled in the Intranasal Foralumab Multiple Sclerosis Expanded Access Program tizianalifesciences.com ↗
Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has allowed its intranasal foralumab non-active Secondary Progressive Multiple Sclerosis (na-SPMS) Expanded Access (EA) Program to expand from 10 patients to a total of 30 patients. |
| 2024-04-22 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Additional Clinical Improvements Among Multiple Sclerosis Patients in its Expanded Access Program tizianalifesciences.com ↗
The data demonstrate multiple improvements in foralumab-treated patients, with 70% showing an improvement in fatigue after six months of follow-up. |
| 2024-04-19 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Study Results from Intranasal Anti-CD3 Foralumab in Multiple Sclerosis Patients with PIRA Highlighted in Neurology Today® tizianalifesciences.com ↗
In this study, five of six patients (83%, 95% confidence interval 44%-97%) showed a qualitative reduction on [F-18]PBR06-PET in multiple brain regions after both 3 and 6 months of nasal foralumab treatment. |
| 2024-04-18 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces New Quantitative PET Imaging Data on Foralumab at the Annual Meeting of the American Academy of Neurology tizianalifesciences.com ↗
Oral presentation of study shows intranasal foralumab attenuates microglial activation and disease progression in multiple sclerosis (MS) patients with PIRA as measured by changes in PET scans |
| 2024-03-05 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Podium Presentation at AD/PD of Nasal Anti-CD3 in Alzheimer’s Disease tizianalifesciences.com ↗
Our research has demonstrated that intranasal rodent anti-CD3 mAb and intranasal fully human anti-CD3 mAb (foralumab) will decrease microglia activation in rodents and humans, respectively. |
| 2024-01-08 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Updated Clinical and PET Scan Findings for Intranasal Foralumab in Two New Multiple Sclerosis Patients tizianalifesciences.com ↗
Upon review of the baseline and three-month [F-18] PBR06 PET scans of the two new na-SPMS EA patients, a qualitative reduction in microglial activity was seen in one of two new patients. |
| 2023-10-18 | Tiziana Life Sciences LTD | Regulatory Tiziana Life Sciences Announces Allowance By FDA For At-Home Dosing Of Intranasal Foralumab For Multiple Sclerosis Treatment tizianalifesciences.com ↗
The U.S. Food and Drug Administration (FDA) has allowed multiple sclerosis patients to take home and self-administer Intranasal Foralumab, a groundbreaking treatment developed by Tiziana Life Sciences. |
| 2023-10-16 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Positive Six-Month Clinical Results in Multiple Sclerosis Patients Treated with Intranasal Foralumab tizianalifesciences.com ↗
Numeric improvements were seen across key multiple sclerosis measures, including the Modified Fatigue Impact Scale, Expanded Disability Status Scale, Timed 25-Foot Walk test, Pyramidal Scores and NeuroQoL™ Fatigue scores. |
| 2023-10-13 | Tiziana Life Sciences LTD | Results Tiziana Announces Positive Qualitative Six-Month PET Scan Results With Intranasal Foralumab Treating Multiple Sclerosis Patients Diagnosed With Non-Active Secondary Progressive MS (na-SPMS) tizianalifesciences.com ↗
When combined with my assessment of the first two Expanded Access patients at six-months, five of the six suggested a reduction in qualitative microglial PET signal. |
| 2023-09-06 | Tiziana Life Sciences LTD | Results Study Validating MoA of Intranasal Foralumab in Alzheimer’s Disease Published in the Prestigious Journal PNAS, Following FDA IND Clearance tizianalifesciences.com ↗
This study shows that intranasal anti-CD3 ameliorates disease in a rodent model of AD by targeting microglial activation in the brain and brain gene expression independent of affecting amyloid beta deposition. |
| 2023-08-15 | Tiziana Life Sciences LTD | Regulatory Tiziana Life Sciences Announces FDA IND Clearance of Intranasal Foralumab for the Treatment of Alzheimer’s Disease tizianalifesciences.com ↗ |
| 2023-06-05 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Reduction in Microglial Activation in a Total of 5 Out of 6 Intranasal Foralumab Expanded Access Patients with Non-Active Secondary Progressive Multiple Sclerosis tizianalifesciences.com ↗ |
| 2023-04-27 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Findings from Intranasal Anti-CD3 mAb Treatment in Intracerebral Hemorrhage at the Annual American Academy of Neurology Conference tizianalifesciences.com ↗
Intranasal anti-CD3 mAb treatment showed a reduction in Intracerebral Hemorrhage injury severity |
| 2023-04-04 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Invitation for Podium Presentation of Research on Intranasal Anti-CD3 mAb in Intracerebral Hemorrhage at the Annual American Academy of Neurology Conference tizianalifesciences.com ↗
Dr. Saef Izzy’s data shows one-month behavioral outcomes improvement in model of intracerebral hemorrhage (hemorrhagic stroke) |
| 2023-04-04 | Tiziana Life Sciences LTD | Results Tiziana Announces Positive Data on Intranasal Anti-CD3 Monoclonal Antibody in Intracerebral Hemorrhage tizianalifesciences.com ↗
Intranasal anti-CD3 monoclonal antibody showed improved motor and cognitive outcomes at one-month post-intracerebral hemorrhage which is very exciting. |
| 2023-03-31 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Anti-CD3 mAb Research for the Treatment of Alzheimer’s Disease to be Presented by Dr. Howard Weiner at the International Conference on Alzheimer’s and Parkinson’s Disease and Related Neurological Disorders Conference tizianalifesciences.com ↗
Our research has demonstrated that intranasal rodent anti-CD3 mAb and intranasal fully human anti-CD3 mAb (foralumab) will decrease microglia activation in rodents and humans, respectively. |
| 2023-03-08 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Publication in Proceedings of the National Academy of Sciences (PNAS) Illustrating the Immunological Basis of the Mechanism of Action for Intranasal Foralumab tizianalifesciences.com ↗
The identification of a unique mechanism associated with nasal foralumab in humans was consistent across patients with COVID, multiple sclerosis and in healthy volunteers. |
| 2023-01-03 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Additional Clinical Improvements in the Second Patient with Non-Active Secondary Progressive Multiple Sclerosis (SPMS) After Eleven Months of Dosing with Intranasal Foralumab tizianalifesciences.com ↗
today announced that the second patient (“EA2”) with non-active secondary progressive multiple sclerosis (SPMS) receiving intranasal foralumab has shown additional clinical improvements since their last reported improvement in September 2022. |
| 2022-11-23 | Tiziana Life Sciences LTD | Results Tiziana Announces Publication of a Peer-Reviewed Article on the Intranasal Administration of Foralumab Demonstrating Modulated Effector CD8+ T cell Function and an Induced T Cell Regulatory Response in Human Subjects tizianalifesciences.com ↗
Third-party research conducted by leading U.S. academic institutions published in a peer reviewed journal Frontiers in Immunology shows a favorable safety profile for intranasally administered foralumab and immunological activity in humans |
| 2022-09-21 | Tiziana Life Sciences LTD | Results Article: Second SPMS Patient Given Foralumab Continues to Improve tizianalifesciences.com ↗ |
| 2022-09-20 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Continued Clinical Improvements in the Second Patient with Secondary Progressive Multiple Sclerosis (SPMS) After Six Months of Dosing with Intranasal Foralumab tizianalifesciences.com ↗
On September 12th, 2022, this patient had walked 100 meters without a cane or need for rest. |
| 2022-08-01 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Presentation at Alzheimer’s Association International Conference® 2022 (AAIC®) Evaluating Intranasal anti-CD3 for the Potential Treatment of Alzheimer’s Disease tizianalifesciences.com ↗
In this study animal models of Alzheimer’s disease (AD) demonstrated that microglia activity was restored and cognition was improved following the dosing of intranasal anti-CD3 monoclonal antibody. |
| 2022-06-08 | Tiziana Life Sciences LTD | Results Tiziana Life Sciences Announces Positive Clinical Results in the Second Patient with Secondary Progressive Multiple Sclerosis (SPMS) Following Three Months of Dosing with Intranasal Foralumab tizianalifesciences.com ↗
The treatment with foralumab, a fully human anti-CD3 monoclonal antibody, was well-tolerated and improved clinical and PET imaging analyses. |
| 2022-04-05 | Tiziana Life Sciences LTD | Regulatory FDA Grants Permission to Enroll up to 8 Additional Secondary Progressive Multiple Sclerosis (SPMS) Patients in the Expanded Access Program with Intranasal Foralumab tizianalifesciences.com ↗ |
| 2022-03-16 | Tiziana Life Sciences LTD | Results Article: Single-patient data suggest Tiziana nose a better way with CD3 in MS tizianalifesciences.com ↗ |
| 2022-03-15 | Tiziana Life Sciences LTD | Results Article: Foralumab as Nasal Spray Safely, Effectively Treats 1st SPMS Patient tizianalifesciences.com ↗
Multiple Sclerosis News Today has published an article regarding Foralumab effectively treating the first SPMS patient |
| 2022-03-10 | Tiziana Life Sciences LTD | Results Tiziana Announces Positive Clinical Data from A Secondary Progressive Multiple Sclerosis Patient Treated for Six Months with Intranasally Administered Foralumab, A Fully Human Anti-CD3 Monoclonal Antibody tizianalifesciences.com ↗
Data show sustained inhibition of microglial activation as assessed by Positron Emission Tomography (PET) along with downregulation of pro-inflammatory cytokines associated with brain inflammation, as well as stabilization of disease as measured by clinical assessments |
| 2022-02-04 | Tiziana Life Sciences LTD | Regulatory Tiziana Announces Submission of Amendment to Investigational New Drug Application to Advance Oral Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, in Patients with Crohn’s Disease tizianalifesciences.com ↗ |
| 2022-01-10 | Tiziana Life Sciences LTD | Regulatory Tiziana Enrolls Second Patient in Ongoing Intranasal Foralumab Evaluation for Secondary Progressive Multiple Sclerosis tizianalifesciences.com ↗
As part of the regulatory process, three-month safety data were submitted to the FDA, seeking permission to treat an additional patient under an Individual Patient Expanded Access Investigational New Drug Application (IND), which has been allowed. |
| 2021-08-17 | Tiziana Life Sciences LTD | Results Tiziana Announces Publication of a Peer Reviewed Article on Data from the Clinical Trial with Intranasally Administered Foralumab, Its Proprietary Fully Human Anti-CD3 Monoclonal Antibody, in Mild to Moderate COVID-19 Patients in Brazil tizianalifesciences.com ↗
Nasally administered Foralumab, once a day for 10 consecutive days, was well-tolerated and produced significant reduction in lung inflammation as assessed by computerized tomography (CT) scanning |
| 2021-05-26 | Tiziana Life Sciences LTD | Results Tiziana Reports Data Indicating Significant Immunomodulation effects on Immune and Inflammatory Biomarkers with Nasally Administered Foralumab in Healthy Volunteers. tizianalifesciences.com ↗
Results exhibiting statistically significant immunomodulatory effects on CD8 cytotoxic T-lymphocytes and other inflammatory biomarkers were observed. |
| 2021-03-30 | Tiziana Life Sciences LTD | Regulatory Tiziana Announces the FDA Has Allowed Treatment for a Secondary Progressive Multiple Sclerosis (SPMS) Patient for the Nasal Administration of Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, Under an Individual Patient Expanded Access Program tizianalifesciences.com ↗ |
| 2021-02-03 | Tiziana Life Sciences LTD | Results CEO Discusses COVID-19 Trial Data in Exclusive Interview tizianalifesciences.com ↗
Dr. Shailubhai also comments on the nearly 2x improvement shown in CT scans of the lungs of patients treated with Foralumab as compared to those in the control group. |
| 2021-02-02 | Tiziana Life Sciences LTD | Results Tiziana Reports Positive Data from the Clinical Study of Nasal Administration with Foralumab, its proprietary fully human anti-CD3 monoclonal antibody, in COVID-19 Patients in Brazil tizianalifesciences.com ↗
The treatment also improved the senses of smell and taste in treated patients. |
| 2020-01-09 | Tiziana Life Sciences LTD | Results Tiziana Reports Phase 1 Clinical Data Demonstrating Oral Treatment with Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, is Well-tolerated in Healthy Volunteers tizianalifesciences.com ↗
All subjects completed the trial without any safety concerns at any of the doses. |
| 2019-09-30 | Tiziana Life Sciences LTD | Results Interim Results for the Six Months Ended 30 June 2019: Advancing pipeline of next generation therapeutics and diagnostics for oncology and immune diseases of high unmet need tizianalifesciences.com ↗
The study was completed in September 2019 and Phase 1 clinical data demonstrated that nasally administered Foralumab, was well-tolerated at all doses. |
| 2019-09-16 | Tiziana Life Sciences LTD | Regulatory Tiziana Life Sciences Announces FDA Approval to Initiate Phase I Clinical Trial with Orally Administered Foralumab in Healthy Volunteers. tizianalifesciences.com ↗ |
| 2019-09-10 | Tiziana Life Sciences LTD | Results Tiziana Reports Phase 1 Clinical Data Demonstrating Nasal Treatment with Foralumab was Well-tolerated and Produced Positive Trend in Biomarkers of Immunomodulation and Anti-inflammation in Healthy Volunteers tizianalifesciences.com ↗
Biomarker analysis showed significant positive immune effects, that were most prominent in the 50 mg cohort with minimal immunomodulatory effects at the 10 µg and 250 µg doses. |
| 2019-05-01 | Tiziana Life Sciences LTD | Regulatory Update on IND Application for Oral Formulation of Foralumab for Treatment of NASH tizianalifesciences.com ↗
Accordingly, we have withdrawn the current IND to include safety data from the ongoing trial with nasal administration and adequately cross-reference the IND for nasal administration with solution of foralumab. |
| 2019-03-20 | Tiziana Life Sciences LTD | Regulatory Tiziana Submits IND Application for Oral Formulation of Foralumab for Treatment of NASH tizianalifesciences.com ↗
Tiziana Life Sciences plc (NASDAQ: TLSA; AIM: TILS), a US and UK biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology and immunology, today announced that it has submitted* an Investigational New Drug application (“IND”) to the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial of enteric-coated capsules of Foralumab in healthy volunteers. |
All press releases naming this drug 116 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 116 releases opens the full record — a long page | ||
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Foralumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07688239 ↗ |
| Known as | NI-0401 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00805909 ↗ |
| Known as | TZLS-0401 | “Foralumab (TZLS-0401) is a fully human IgG1 monoclonal antibody directed against the CD3-epsilon (or CD3ε) antigen expressed on the surface of a type of white blood cell called...” NCT03291249 ↗ |
| Known as | TZLS-401 | “Foralumab TZLS-401 100 µg” NCT06890923 ↗ |
| Modality | Monoclonal antibody | “NI-0401 (anti-CD3 mAB)” NCT00630643 ↗ |
| Route | Intravenous | “daily intravenous NI-0401 treatment” NCT00630643 ↗ |